PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS

Phase 3 Completed 70 enrolled Marqués de Valdecilla Research Institute (IDIVAL) Gerencia Atencion Primaria Area 3 · collab Gerencia de atención primaria área 1 · collab Gerencia de atención primaria área 2 · collab Gerencia de atención primaria área 4 · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.

Timeline

Start: 2020-08-19
Primary completion: 2022-06-01
Completion: 2022-10-11

Publications

Estebanez EB, Alconero LL, Fernandez BJ, Marguello MG, Caro JCL, Vallejo JD, Sampedro MF, Cacho PM, Espiga CR, Saiz MMG. The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care-COLCHICOVID study. Trials. 2021 Sep 6;22(1):590. doi: 10.1186/s13063-021-05544-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Colchicine	Small molecule	0.5 mg	Oral
Background	Acetaminophen	Small molecule	—	—

PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS

Summary

Timeline

Publications

Drugs

Indications